Seres Therapeutics (NASDAQ:MCRB) rockets 173% premarket on robust volume in reaction to positive results from a Phase 3 clinical trial, ECOSPOR III, evaluating lead candidate SER-109 for the treatment of recurrent Clostridium difficile (C. diff) infection (CDI).
The study met the primary endpoint demonstrating a statistically significant 30.2% decrease in the proportion of patients who experienced a recurrence in CDI within eight weeks compared to placebo. Specifically, 11.1% of treated patients experienced a CDI recurrence versus 41.3% in the control arm.
88.9% of patients receiving SER-109 showed sustained clinical responses.
SER-109’s safety profile was comparable to placebo.
The results should be sufficient to support a U.S. marketing application.
The company says SER-109 is a highly purified consortia of spore-based commensal bacteria manufactured under GMP conditions, adding that its manufacturing process inactivates a number of potential pathogens, including species of E. coli and viruses like SARS-CoV-2.
Management will host a conference call at 8:30 am ET to discuss the results.
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